Author: Peter

Elko County encourages residents to thank their health care provider...County commissioners proclaimed March 30 as Health Professional Recognition Day...Commissioner Delmo Andreozzi requested the proclamation..."Really and truly the health care professional, with the shortage that we see throughout the nation, can go anywhere they want to," he said. "They are a highly sought after resource, yet the people that we have here choose to be here and provide services. They are loyal, hardworking men and women who dedicate their lives to helping people feel better and provide excellent treatment. I think it’s really fitting that we take an opportunity to just pause and reflect for a moment about their contribution to our community, and just say thank you. Another big part of recruitment, in my mind, is retention. I think if the health care field understands that we appreciate them, I think that is a small step that goes a long way."

...Johnson & Johnson has halted all global advertising on the video-sharing site YouTube in response to concerns product marketing appeared next to offensive content such as hate speech…J&J joins a growing list of large corporations, including major advertiser AT&T, that have opted to pull advertising from running on the Google-owned media channel...Alarm began to spread following an investigation by the British newspaper The Times which found advertising from well-known brands appeared next to content from extremist groups. ISBA, a U.K. advertising association with over 400 corporate members, urged Google shortly thereafter to review its policies and withdraw any ad inventory it could not guarantee wouldn't appear next to offending material

Biogen's defense of its blockbuster multiple sclerosis treatment Tecfidera (dimethyl fumarate) got a lift...after the U.S. Patent Trial and Appeal Board rejected a patent challenge by a group affiliated with hedge fund manager Kyle Bass...The...Board upheld Biogen's '514 patent on the 480 mg dose of Tecfidera, boosting the chances Biogen will be able to maintain patent protection on the top-selling drug for longer...Despite the positive development, Biogen hasn't fully put to rest the patent challenges surrounding Tecfidera. So-called interference proceedings between the company and Forward Pharma are still ongoing at the Patent Trial and Appeal Board, which could force Biogen to pay Forward royalties on sales of Tecfidera.

APhA releases position on health care...the future of health care continues to be a major focus of Congress, the American Pharmacists Association emphasizes the importance of patients’ access to care, including pharmacist-provided services and safe and affordable medications. APhA Executive Vice President and CEO Thomas E. Menighan issued the following statement further explaining APhA’s position on health care:

Consistent with our recommendations related to the Affordable Care Act and other health care reforms, APhA continues to call for policies that support patient access to and coverage of —pharmacists’ patient care services, the pharmacy of their choice, and safe and affordable medications. An important component to providing access is ensuring adequate reimbursement to pharmacists for their patient care services and to pharmacies for medications and other products. Securing enactment of these policies increases access, improves quality and decreases costs...APhA strongly advocates for a health care system better structured to optimize the skills and expertise of practitioners, including pharmacists, to provide the best care to patients and value to the system…

Europe's medicines regulator has recommended the suspension of more than 300 generic drug approvals and drug applications due to "unreliable" tests conducted by Indian contract research firm Micro Therapeutic Research Labs...The decision, announced by the European Medicines Agency...is the latest blow for India's drug-testing industry, which has run into a series of problems with international regulators in recent years...The inspections identified several concerns at the company’s sites regarding misrepresentation of study data and deficiencies in documentation and data handling...there is no evidence of harm or lack of effectiveness of the medicines, which include generic versions of many common prescription pharmaceuticals, including blood pressure tablets and painkillers...Drug tests carried out at Indian contract research organizations have been key in getting a huge array of generic medicines approved for sale around the world over many years…In the wake of such trial data scandals, many large drugmakers have been shifting more critical trials back to the United States and Europe over the last three years...

HHS again has delayed enforcement of a final rule that would penalize drugmakers that deliberately overcharge providers for drugs purchased under the 340B drug discount program...The federal 340B program requires drug manufacturers to provide outpatient drugs to eligible health care providers at discounts ranging from 20 to 50 percent...the program has come under scrutiny, with some questioning the amount of charity care participating hospitals are providing...Under the final rule...drugmakers that "knowingly and intentionally" overcharge providers for drugs purchased through the program will face a fine of up to $5,000 per offense. The drugmakers also have to repay the overcharge...The rule took effect on Feb. 28 and was scheduled to be enforced beginning April 1...HHS again delays enforcement date...HHS in an interim rule published Monday in the Federal Register again delayed the rule's enforcement date, this time to May 22.

Venezuelan President Nicolas Maduro said on Friday he has asked the United Nations to help the South American nation alleviate medicine shortages, which have become increasingly severe as the oil-producing nation's economic crisis accelerates...Triple digit inflation and a decaying socialist economic model have left medications ranging from simple anti-inflammatory drugs to chemotherapy medication out of reach for most Venezuelans...The Venezuelan Pharmaceuticals Federation estimates some 85 percent of drugs are unavailable to the country's citizens...Maduro often blames the deteriorating economy and widespread shortages of goods on an "economic war" led by opposition politicians with the help of the United States...Critics say the problems are the result of dysfunctional price and currency controls that have decimated private industry.

Pharmacy benefit managers and tech startups are responding to underinsurance and the onslaught of high-deductible health plans by cutting out insurers in the quest to help patients lower their prescription drug costs...Two PBMs have launched discount programs for patients to use outside of any insurance coverage they might have. It's a notable contrast to PBMs' main business serving as third-party administrators of prescription drug coverage for insurers and employers...These efforts come as a budding industry has sprung up around helping consumers and employers rein in prescription drug costs. Startups like Blink Health and RefillWise offer pharmacy cards that provide consumers with negotiated discounts if they don't use their prescription coverage, while some insurers and pharmacy benefit managers, along with tech firm Castlight Health, are attempting to allay consumer and employers' concerns about drug costs by building apps that offer price transparency to physicians or patients.

For years, the FDA’s adverse events system has been derided because of its largely voluntary nature — only drug companies, not doctors or patients, are required to report problems. As a result, the system likely only was capturing a small percentage of cases...In recent years, the number of reports filed has been multiplying, prompting more independent researchers and drug companies to use the data as a way to detect safety problems...The surge in reports could indicate a growing number of harmed patients or more vigilant reporting of adverse events, a goal of the FDA. Experts say both likely play a role...Twelve years ago, there were 206,000 reports of side effects from medications filed with the FDA — complaints as frivolous as flatulence, as serious as death...By 2015, the most recent full year of data, the number had grown to 1.2 million...

China's FDA published a slate of suggested amendments to its foreign drug registration rules...which could dramatically revamp the country’s pharmaceutical market landscape by eliminating hurdles that slow approvals of Western drugs. Pharma companies quickly hailed the changes...the new rules would allow foreign drugmakers to file for a new drug approval using data from international, multicenter trials, so long as those trials include China as a study site. Translation: No China-specific trial applications would be required for those foreign drugs...When finalized and implemented, these policies will encourage biopharmaceutical innovation and accelerate the approval process for new medicines...They will also pave the way for China's integration into the system for multiregional clinical trials that undergirds global drug development...